ISPE/DIA Workshop on Computer Systems Compliance “Maintain Data Integrity to Reduce Risk for the Patient”

Whilst 10 years ago, Computerized Systems Validation was a priority for many organisations, the today’s industry and regulators key focus is on data integrity. As a prerequisite for end to end clinical data integrity, computerized systems have to be validated and to be kept in a validated state. In particular in large Pharmaceutical Organizations and with full service providers, there is a level of Systems, Process, Organizational and Geographical Complexity that require another layer of governance and oversight than the typical controls described in numerous publications. Furthermore, additional data collection tools such as ePRO systems and eSource data concepts have to be properly integrated in clinical study setups.
The objective of this session will be to consider how eClinical IT systems and platforms can enable end-to-end data integrity in today’s context of further going electronic and paperless, implementing global data management operations, insourcing of resources and outsourcing of services. In addition, Systems retirement and data storage and archiving will be addressed.